Warning of increased transmission of coronavirus during the winter season, health minister Harsh Vardhan said on Sunday that the government is deliberating the emergency use authorisation of Covid vaccines in India. “Adequate safety and efficacy data is required for emergency-use authorisation vaccine approval for ensuring patient safety. Further course of action will depend on the data generated,” he said.
Very few countries such as China and UAE have allowed such emergency authorisation for Covid vaccine. Russia has a temporary registration of its vaccine Sputnik V till January 2021, subject to phase-III trial. If a regulator sees a reasonable likelihood of a drug or vaccine being useful and lives of people under threat if not used, it can allow its use for public health emergencies.
The Drug Controller General of India under the provisions of the Drugs and Cosmetics Act allowed emergency use of Remdesivir and Favipiravir for treatment of mild to moderate cases of Covid-19. The go-ahed in some cases is granted with conditions such as a written consent and post-marketing surveillance by the drug company on a certain number of patients to check the safety and efficacy of the drug.
The government is planning to roll out the Covid-19 vaccine by prioritizing target groups in the entire population and that the initial supply is expected to be limited, Vardhan said while addressing a weekly social-media dialogue.
He said that the prioritisation of groups for Covid-19 vaccine will be based on two key considerations: occupational hazard and risk of exposure to infection, and the risk of developing severe disease and increased mortality. “India is looking at the availability of several different types of vaccines, of which some may be suitable for a particular age group while others may not be.”
Among the three front-runners for Covid vaccine in India, the vaccine by Serum Institute of India and Bharat Biotech requires two doses while the Cadila Healthcare vaccine requires three. The Government is open to assessing the feasibility of introducing several Covid-19 vaccines in the country as per their availability for the Indian population, Vardhan said.
With the upcoming festive season raising concerns of a wider spread of the disease the health minister said,” No religion or God says you have to celebrate in an ostentatious way, that you have to visit pandals and temples and mosques to pray.”
With sporadic cases of reinfection surfacing in various states, the Indian Council of Medical Research (ICMR) is studying the true-burden of such cases. Vardhan said that actual reinfection would mean a fully recovered person getting infected by a freshly introduced virus in their body, belonging to the same or different strain. “ICMR is commissioning a study to understand the true burden of re-infected cases. Results will be shared in a couple of weeks.”
Vardhan also said that the Feluda paper strip test will be made available in the next few weeks. The test developed by Tata group and the Council of Scientific and Industrial Research (CSIR) using the gene editing technology has been approved by the Drug Controller General of India for a commercial launch.
Private lab tests and trials on over 2,000 patients at the Institute of Genomics and Integrative Biology (IGIB) have shown higher accuracy in Feluda test compared to the RT-PCR test, health ministry statement said.